By: Wentworth S.B. No. 1193
(In the Senate - Filed February 26, 2009; March 13, 2009,
read first time and referred to Committee on Health and Human
Services; April 24, 2009, reported adversely, with favorable
Committee Substitute by the following vote: Yeas 9, Nays 0;
April 24, 2009, sent to printer.)
COMMITTEE SUBSTITUTE FOR S.B. No. 1193 By: Deuell
A BILL TO BE ENTITLED
AN ACT
relating to the maintenance and service of certain medical devices
in health care facilities; providing a criminal penalty.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subchapter B, Chapter 431, Health and Safety
Code, is amended by adding Section 431.0215 to read as follows:
Sec. 431.0215. ADDITIONAL PROHIBITED ACTS; CRIMINAL
PENALTY. (a) In this section, "facility" means a hospital,
ambulatory surgical center, physician's office, or medical clinic
that is authorized under the laws of this state to provide health
care in this state.
(b) Except as provided by Subsection (c), a person may not
calibrate, repair, or perform preventive maintenance on or
otherwise service a device designated by the United States Food and
Drug Administration as a class II or class III medical device in a
facility unless the person:
(1) holds at least an associate of applied science
degree issued by an accredited college or university in engineering
or as a biomedical equipment technician or medical imaging
specialist, or holds a similar degree focused on the service,
maintenance, or service and maintenance of medical devices;
(2) holds satisfactory evidence of completion of a
program of service, maintenance, or service and maintenance of
medical devices issued by the United States military;
(3) holds at least an associate degree in an
electronics field or an information management field and has been
actively engaged in the service, maintenance, or service and
maintenance of medical devices for at least two of the preceding
four years under the direct supervision of an individual who meets
the requirements of Subdivision (1) or (2); or
(4) holds satisfactory evidence of successful
completion of service, maintenance, or service and maintenance
training from a medical device manufacturer, provided the person
only provides service or maintenance for devices made by that
manufacturer unless the person otherwise meets the requirements of
Subdivision (1), (2), or (3).
(c) Subsection (b) does not apply to:
(1) the calibration, repair, maintenance, or service
of a class II or class III medical device that is used only for
teaching and research purposes;
(2) in-service or software upgrades of a medical
device performed by an employee or authorized sales representative
of a medical device manufacturer; or
(3) routine evaluations specified by the medical
device manufacturer performed by the owner or person designated by
the owner of the medical device.
(d) A person commits an offense if the person violates
Subsection (b). An offense under this subsection is a Class C
misdemeanor.
SECTION 2. This Act takes effect September 1, 2009.
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